1. Field of the Invention
The systems and methods of this invention relate to direct electrical stimulation of the gastrointestinal system of the body as a treatment for a variety of medical conditions. Specifically, the present invention relates to methods and apparatus for applying such stimulation to selected portions of the gastrointestinal system without the use of conventional lead/electrode systems.
2. Description of the Background Art
Electrical stimulation of the gastrointestinal system or gastrointestinal tract for the purpose of controlling gastrointestinal activity has been known and actively practiced for several decades. Application of an electrical field between electrodes to gastrointestinal tissue is known to affect the motility and electromotor conduct of the gastric tract; for example, it has been used in the treatment of eating disorders (e.g., obesity, thinness, bulimia, anorexia). For example, applying specific electrical pulses to the selected areas of the stomach can induce a sense of satiety. Disturbances in electromotor activity in diabetic gastroparesis, reflux in the upper digestive tract, and numerous other gastroenterological functional pathologies can be observed with electrophysiologic sensing and also treated with application of electrical stimulation. Electrical stimulation of other locations in the tract can induce voiding or can be used as a treatment for gastric reflux. These applications are currently practiced using both implanted and externally applied devices.
Depending on the individual patient, gastrointestinal stimulation can effectively modify signal pathways along the tract and thus provide relief of symptoms or control of bodily function. Treatment regimens and targeted gastrointestinal tissue locations are known in related art through use of current, common stimulation devices and methods. Currently, implanted devices for gastrointestinal tissue stimulation are made by companies such as IntraPace and Transneuronix.
As illustrated in FIG. 1a, the gastrointestinal system is essentially a long tube running from the mouth to the anus consisting of four main sections including the oesophagus, the stomach, the small intestines, and the large intestines. These specialized sections are capable of digesting material place in the mouth and extracting components useful to the body as the material passes through the system. Material that can not be used or that has been processed is expelled from the end of the tube at the anus. The system is under hormonal control, with the presence of food in the mouth triggering off a cascade of hormonal actions; when there is food in the stomach, different hormones activate acid secretion, increased gut motility, enzyme release etc. As illustrated in FIG. 1b, the stomach is a ‘j’-shaped organ, with two openings—the esophageal and the duodenal, and four regions—the cardia, fundus, body and pylorus. Each region performs different functions; the fundus collects digestive gases, the body secretes pepsinogen and hydrochloric acid, and the pylorus is responsible for mucus, gastrin and pepsinogen secretion. The body uses this arrangement to process food and supply nutrients to the system.
In one early application of electrical gastrointestinal tissue stimulation, an electrode was passed down the esophagus to the stomach and electrical stimulation applied between the electrode and an electrode placed on the patient's abdomen. This induced peristaltic activity within the system. This was an external application of the electrical stimulation system. More recently, the concept has been extended to apply an implantable system into the stomach either as a self-contained stimulator or with electrodes on leads attached to the stomach and then connected to a subcutaneous implanted pulse generator. These systems have been found useful in treatment of obesity both for improving motility in patients and for providing a feeling of satiety to reduce intake.
In the context of this application, Gastrointestinal Tissue Stimulation (GTS) refers to treatments for a variety of medical conditions that apply electrical stimulation directly to gastrointestinal tissues. Currently available stimulator systems for GTS are fully implanted electronic devices placed within the stomach or placed subcutaneously under the skin and connected via insulated metal lead(s) to electrodes which are invasively inserted into, around, or onto gastrointestinal tissue. An implanted GTS system contains a battery to power the system. Some implanted GTS systems use an RF wireless connection instead of a battery to power the implanted device. In these RF systems, a receiver device is implanted subcutaneously and a transmitter is worn on the outside of the body. The antenna are tuned to each other and aligned such that control information and power is transmitted to the receiver and then directs the electrical impulses to the electrodes through the leads. The external transmitter contains batteries to power the transmission. All systems have the capability to externally adjust settings of the implanted system through a programming device.
In some GTS systems, electrical energy is delivered through lead wires to the electrodes; in other applications, the self-contained devices incorporate a battery with electrodes disposed on the outer surfaces of the device. For GTS, implanted electrodes are positioned on, around, or in close proximity to the gastrointestinal tissue to be stimulated. GTS uses the implanted electrodes to deliver a variety of stimulation modalities for propagation along the gastrointestinal tissue with the electric pulse waveform defined by a plurality of variables, including: pulse width, pulse frequency (Hz) or duty cycle, amplitude (V), and waveform shape (e.g., mono-phasic or bi-phasic).
GTS is used for treatment of motor disorders of the stomach, such as duodenogastric and gastroesophageal refluxes and relapsing duodenal peptic disorders (ulcer or phlogosis); and for treating obesity and other syndromes related to motor disorders of the stomach.
As described above, GTS devices are battery-powered electronic devices implanted and often connected via insulated metal lead(s) to electrodes which are either placed on the stomach or in the stomach or otherwise within or on the gastrointestinal tissues selected for stimulation. The implanted electrodes for GTS are positioned on leads that may be placed percutaneously, through needle punctures, or through minimally invasive surgical procedures such as laparoscopic methods, or through direct surgical access to position the electrodes on, around, or in proximity to the targeted gastrointestinal tissue. The implanted leads are then subcutaneously tunneled to the pulse generator (also referred to as a controller) that is implanted in a subcutaneous pocket. The use of these lead wires is associated with significant problems such as complications due to infection, lead failure, lead migration, and electrode/lead dislodgement. Application of electrodes to the gastrointestinal tissues can be difficult, because the stomach is uniquely designed to pass material through the system; consequently, electrodes are often expelled through the system itself.
Other prior art has attempted to deal with the complications and limitations imposed by the use of electrical leads. For example, self-contained implantable microstimulators and remotely powered microstimulators implanted through the esophagus into gastrointestinal tissue have been described; however, each approach suffers from some significant limitation. A self-contained microstimulator must incorporate a battery or some other power supply; this imposes constraints on size, device lifetime, available stimulation energy, or all three.
For leadless solutions in other similar stimulation applications, remotely powered devices have previously utilized either radiofrequency (RF) or electromagnetic transformer power transmission. RF energy transmission, unless the transmitting and receiving antennae are placed in close proximity, suffers from inefficiency and limited safe power transfer capabilities, limiting its usefulness in applications where recharging or stimulation must be accomplished at any significant depth (>1-2 cm) within the body, in particular where it is desired to permanently implant both the transmitter and receiver-stimulator. Electromagnetic coupling can more efficiently transfer electrical power, and can safely transfer higher levels of power (devices with capacity in excess of 20 Watts have been produced), but again relies on close proximity between transmitting and receiving coils, or the utilization of relatively large devices for deeper (5-8 cm maximum) implantation.
The methods and apparatus of the current invention utilize vibrational energy, particularly at ultrasonic frequencies, to overcome many of the limitations of currently known solutions for selected gastrointestinal tissue stimulation, by achieving a gastrointestinal tissue stimulation capability without the use of leads connected to a stimulation controller/pulse generator. It is not the intent to limit the scope of this invention to the gastrointestinal tissues in the description but rather to provide a broad solution for stimulation of any selected gastrointestinal tissue without the use of leads.
The following patents, all of which are incorporated in this disclosure in their entirety, describe various aspects of using electrical stimulation for achieving various beneficial effects by selected gastrointestinal tissue stimulation. U.S. Pat. No. 3,411,507 titled “Method of Gastrointestinal Stimulation with Electrical Pulses” by Wingrove describes an application for stimulation of the stomach with an external stimulator and a lead placed down the throat into the stomach. U.S. Pat. No. 7,054,690 titled “Gastrointestinal stimulation device” by Imran describes fixation of electrodes in an implantable application for stimulation of the gastrointestinal tissue as a treatment for obesity or other control of stomach function. U.S. Pat. No. 6,535,764 titled “Gastric treatment and diagnosis device and method” by Imran et al. describes an implantable application for stimulation and devices for attaching electrodes to the stomach. U.S. Pat. No. 6,321,124 titled “Implant device for electrostimulation and/or monitoring of endo-abdominal cavity tissue” by Cigaina describes an implantable application for stimulation of the gastrointestinal tissue as a treatment for a variety of digestive disorders and electromotor control of the intestines. U.S. Pat. No. 5,423,872 titled “Process and device for treating obesity and syndromes related to motor disorders of the stomach of a patient” by Cigaina describes an implantable application for stimulation of the gastrointestinal tissue as a treatment for obesity. U.S. Pat. No. 7,054,689 titled “Fully implantable neurostimulator for autonomic nerve fiber stimulation as a therapy for urinary and bowel dysfunction” by Whitehurst et al. describes an implantable microstimulator used generally for stimulation of gastrointestinal tissue. U.S. Pat. No. 6,037,704 titled “Ultrasonic Power Communication System” by Welle describes the use of ultrasound energy transfer from a transmitter to a receiver for purposes of powering a sensor or actuator without being connected by a lead/wire. U.S. Pat. No. 6,366,816 titled “Electronic Stimulation Equipment with Wireless Satellite Units” by Marchesi describes a tissue stimulation system based on a wireless radio transmission requiring the charging of a battery at the receiver and separate command signals used to control the delivery of stimulation. German patent application DE4330680A1 titled “Device for Electrical Stimulation of Cells within a Living Human or Animal” by Zwicker describes a general approach to power transfer using acoustic energy for tissue stimulation.